Cell and gene therapies (CGT) represent disruptive advancements in medicine by curing the most dramatic human diseases, including terminal cancers. Making these therapies accessible for large patient populations represents a major challenge, given the lack of global manufacturing capacity that is observed today. This session will provide an overview on cell and gene therapy manufacturing, challenges and bottlenecks and identify future trends to debottleneck manufacturing and make CGT widely accessible (including continuous manufacturing of viral vectors). Discussions will also address current initiatives for training of highly qualified personnel to ensure workforce supply and how international collaborations can accelerate advancements in the field.
Manufacturing of expanded hematopoietic stem cell-based therapies: challenges on the path to commercialization
Sven Ansorge (ExCellThera, Canada)
UK Cell and Gene Therapy Catapult: A model for the world?
Nuno Madeira Do O (Cell and Gene Therapy Catapult, UK)
Steven Keizer (Centre for Commercialization of Regenerative Medicine, Canada)
Perspective from an organisation looking at formalizing testing
Fouad Atouf (Unites States Pharmacopeia – USP, USA)